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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2018
Event Type  Malfunction  
Manufacturer Narrative

The instruments on the loading cart were reprocessed prior to use in patient procedures. The user facility stated an employee began to pull the transfer carriage away from the sterilizer when the loading cart became unstable and fell off the front of the transfer carriage to the ground. A steris service technician arrived on-site, inspected the unit, and identified the locking mechanism on the transfer carriage was not properly locking the loading cart to the transfer carriage. The technician identified that the locking mechanism was not operating properly due to improper maintenance of the unit. The 66" transfer carriage is not under steris contract for maintenance services, all maintenance is performed by user facility personnel. The transfer carriage subject of the reported event was damaged as a result of the event and was removed from service at the user facility. The user facility has several additional 66" transfer carriages that are in use at the user facility. The steris service technician inspected the locking mechanism on the remaining transfer carriages located at the facility while on-site, and made adjustments as necessary. The technician notified the user facility of the proper maintenance practices required for the 66" transfer carriage while on-site. No additional issues have been reported with the transfer carriages in use at the user facility.

 
Event Description

The user facility reported the loading cart fell from their 66" evolution transfer carriage while unloading their evolution sterilizer. No injury, procedure delay, or cancellation was reported.

 
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Brand Name66" EVOLUTION TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE TO STERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key7286413
MDR Text Key100780398
Report Number3005899764-2018-00013
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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